Intramuscular versus intravenous therapy for prehospital status epilepticus.
Intramuscular versus intravenous therapy for prehospital status epilepticus.
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DOI：
10.1056/nejmoa1107494
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发表时间：
2012-02-16
期刊：
影响因子：
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通讯作者：
NETT Investigators
中科院分区：
文献类型：
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作者：
Silbergleit R;Durkalski V;Lowenstein D;Conwit R;Pancioli A;Palesch Y;Barsan W;NETT Investigators
静脉注射苯二氮卓类药物早期终止长时间癫痫发作可改善预后。为了更快和更可靠的管理，护理人员越来越多地使用肌内途径。这项双盲、随机、非劣效性试验比较了肌肉注射咪达唑仑与静脉注射劳拉西泮对护理人员治疗的儿童和成人癫痫持续状态的疗效。对于惊厥持续时间超过5分钟且在医护人员到达后仍在惊厥的受试者，通过肌内自动注射器或静脉输注给予研究药物。主要结局是到达急诊室时无癫痫发作，无需急救治疗。次要结局包括气管插管、复发性癫痫发作和相对于惊厥发作停止的治疗时间。本试验检验了肌内咪达唑仑非劣效于静脉劳拉西泮的假设，其边际为10个百分点。在到达急诊室时，448名受试者中有329名没有癫痫发作，没有接受补救治疗咪达唑仑组为73.4%，445例中有282例劳拉西泮组为63.4%，（绝对差异，10个百分点; 95%置信区间，4.0 - 16.1;非劣效性和优效性均P<0.001）。两个治疗组在气管插管需求（肌内咪达唑仑组14.1%的受试者和静脉劳拉西泮组14.4%的受试者）和癫痫发作复发（分别为11.4%和10.6%）方面相似。在到达急诊室前癫痫发作停止的受试者中，肌内咪达唑仑组至活性药物治疗的中位时间为1.2分钟，静脉劳拉西泮组为4.8分钟，从活性药物治疗至惊厥停止的相应中位时间为3.3分钟和1.6分钟。两组的不良事件发生率相似。对于癫痫持续状态的受试者，肌内咪达唑仑至少与静脉注射劳拉西泮一样安全有效。（由国家神经疾病和中风研究所和其他机构资助; ClinicalTrials.gov编号，NCT 00809146。
Early termination of prolonged seizures with intravenous administration of benzodiazepines improves outcomes. For faster and more reliable administration, paramedics increasingly use an intramuscular route. This double-blind, randomized, noninferiority trial compared the efficacy of intramuscular midazolam with that of intravenous lorazepam for children and adults in status epilepticus treated by paramedics. Subjects whose convulsions had persisted for more than 5 minutes and who were still convulsing after paramedics arrived were given the study medication by either intramuscular autoinjector or intravenous infusion. The primary outcome was absence of seizures at the time of arrival in the emergency department without the need for rescue therapy. Secondary outcomes included endotracheal intubation, recurrent seizures, and timing of treatment relative to the cessation of convulsive seizures. This trial tested the hypothesis that intramuscular midazolam was noninferior to intravenous lorazepam by a margin of 10 percentage points. At the time of arrival in the emergency department, seizures were absent without rescue therapy in 329 of 448 subjects (73.4%) in the intramuscular-midazolam group and in 282 of 445 (63.4%) in the intravenous-lorazepam group (absolute difference, 10 percentage points; 95% confidence interval, 4.0 to 16.1; P<0.001 for both noninferiority and superiority). The two treatment groups were similar with respect to need for endotracheal intubation (14.1% of subjects with intramuscular midazolam and 14.4% with intravenous lorazepam) and recurrence of seizures (11.4% and 10.6%, respectively). Among subjects whose seizures ceased before arrival in the emergency department, the median times to active treatment were 1.2 minutes in the intramuscular-midazolam group and 4.8 minutes in the intravenous-lorazepam group, with corresponding median times from active treatment to cessation of convulsions of 3.3 minutes and 1.6 minutes. Adverse-event rates were similar in the two groups. For subjects in status epilepticus, intramuscular midazolam is at least as safe and effective as intravenous lorazepam for prehospital seizure cessation. (Funded by the National Institute of Neurological Disorders and Stroke and others; ClinicalTrials.gov number, NCT00809146.)